With the global market for probiotic products showing good
growth, therapeutic usage is also slowly gaining acceptance in the Indian market.
Sushmi Dey finds out what research is being done

Daily
piyo, healthy jiyo, the jingle might sound like that of any other health
drink but this time it is all about a drink that contains live micro organisms.
'Probiotics' is the more commonly used word for it. The concept has come a long
way from making probiotic drinks and yoghurts popular with catchy punch lines
to using probiotics in making drugs for serious diseases like diarrhoea, periodontal
diseases and inflammatory bowel diseases. No wonder, the Rs 120 crore probiotic
drug market, growing at about 40 percent per annum in India, is attracting pharmacos
who want to get first mover advantage. While new insights into the benefits
offered by probiotics are boosting the market still further, major research
driven pharmacos like Alkem Laboratories, Dr Reddy's Laboratories (DRL), Glenmark,
and Ranbaxy Laboratories are taking interest in the science behind probiotics.

Good bacteria

"Probiotics
might theoretically cause infections that need to be treated with antibiotics,
especially in people with underlying health conditions"

The human digestive tract is home to over 400 species of microorganisms,
of which some are good ones while others are harmful to our body. Probiotics
is the answer to keep the harmful ones at bay. According to the definition adopted
by WHO, probiotics are "live microorganisms which when administered in
adequate amounts confer a health benefit on the host." In simpler words,
probiotics are new generation biotechnology drugs and dietary supplements developed
from yeast or lactic acid bacteria. According to Dr Sharad Kasarle, Vice President,
R&D Nutraceuticals, Alkem Laboratories, in most cases probiotics are bacteria.

These bacteria are similar to those naturally found in people's guts, especially
in breastfed infants, which allow them natural protection against many diseases.
Most often, the bacteria come from two groups, Lactobacillus or Bifidobacterium.
Within each group, there are different species and within each species there
are different strains or varieties.

Apart from bacteria, there are also a few common probiotics in the form of yeasts.
For instance, Saccharomyces boulardii is a yeast and is different from bacteria.

Probiotic bacteria are resistant to gastric, bile and pancreatic juices and
hence reach the intestines alive in large numbers, whereas on reaching the acidic
environment of the stomach, most ingested live bacteria die due to gastric acid.
"A good probiotic agent needs to be non-pathogenic and non-toxic, resistant
to gastric acid and bile and must reach the intestines alive in large numbers.
It should transiently grow in the gut and impart health benefits to the host,"
says Dr Neerja Hajela, Head-Science Activities, Yakult India.

For good health

"It
is critical to understand that any probiotic food or drug has to have a
bare minimum quantity of bacteria to be effective"

- Kanwaljeet S Chadha
Country Head
CD Pharma India

Probiotic drugs are designed to replenish the good bacteria
in our guts and help improve microbial balance within patients' body. Experts
suggest that probiotic bacteria belong to the natural flora with low or no pathogenicity
and show functions that are important for the health and well-being of the host.

Of more than 100 trillion bacteria present in the human gut,
it is important to ensure that the beneficial bacteria in the gut outnumber
harmful ones. "Probiotics have a tendency to grow in the intestines where
they increase number of beneficial bacteria and inhibit growth of harmful bacteria
thus maintaining a balance between beneficial and harmful bacteria," says
Hajela.

When illness, use of antibiotics, stress, irregular diet etc disrupt the natural
balance and harmful bacteria increases in number, it results in diseases and
ill health. "Consumption of probiotics as a part of daily diet helps to
regulate the level of beneficial bacteria and reinforces the barrier against
harmful pathogenic organisms. Their regular intake helps improve digestion,
maintain immunity and prevent infectionsthe key to a long disease free
life," suggests Hajela.

Therapeutic usage

Since the last decade there is a spread of awareness about the beneficial effects
of probiotics. While experts say that additional controlled studies are required
to clearly define safety and efficacy, probiotics have demonstrated an ability
to prevent and treat a variety of conditions and infections.

Effective use of probiotics could decrease patients' exposure
to antimicrobials. "Probiotics normally prevent proliferation of pathogenic
bacteria in the gut. So whenever they are suspected to be deficient or whenever
massive infection of the gut with pathogenic bacteria is suspected, probiotics
are administered to counter the balance in favour of probiotics or healthful
bacteria," says Rakesh Tandon, Head-Department of Gastroenterology, Pushpawati
Singhania Research Institute for Liver, Renal and Digestive Diseases. No wonder,
the use of probiotics as therapeutic agents for gastrointestinal disorders is
rapidly moving into clinical usage. For instance, probiotics is useful in treating
antibiotic induced diarrhoea or infectious diarrhoea, travellers' diarrhoea,
infantile diarrhoea, constipation, Salmonella and Shigella infections, lactose
intolerance and flatulence.

There is also encouraging evidence for the use of probiotics to prevent and
treat infections of the urinary tract or female genital tract. Probiotics are
also useful in treating irritable bowel syndrome and inflammatory bowel diseases
like ulcerative colitis and Crohn's disease. According to Kasarle, probiotics
can also treat infection with Helicobacter pylori, a bacterium that causes most
ulcers and many types of chronic stomach inflammation.

Studies carried out over the years have shown that probiotics can treat dental
problems such as periodontitis, gingivitis and halitosis. Recently, US-based
VSL Pharma announced the introduction of its patented probiotic drug 'Inersan'
to address the problem of weak gums in India. The drug is to be marketed by
Ranbaxy Laboratories. "Periodontitis, gingivitis and halitosis are common
dental problems which if ignored can lead to more serious complications. Dental
practitioners in India currently do not have any specialised prescription product
for these conditions and Inersan tablets address this need for the segment,"
says Sanjeev Dani, Senior Vice President and Regional Director Asia and CIS,
Ranbaxy Laboratories. Periodontitis is a gum disease which in early stages is
painful and causes swollen and bleeding gums. If left untreated, the disease
can lead to serious infection and eventually may cause tooth loss. Though the
problem might not look bigger, studies depict that gum diseases can affect a
person's overall health. For instance, cardiac ailment patients should be more
careful to avoid periodontitis since the bacteria from the mouth can cause clotting
problems in the cardiovascular system and increase the risk of heart attacks.

Interestingly, recent tests conducted by scientists at UK-based University of
Ulster suggest that probiotic drugs/drinks could also help reduce cancer progression
or recurrence of cancer as the bacteria have an anti-cancer effect in the bowel
which limits the build up of genetic damage in cells and stops them from growing
out of control.

Probiotics are increasingly preferred over antibiotics by doctors. Reason being,
antibiotics reduce the immunity of patients, whereas probiotics help enhance
immunity. "There are cells in the digestive tract connected with the immune
system. If you alter the microorganisms in a person's intestinal tract by introducing
probiotic bacteria, you can affect the immune system's defences," explains
Kasarle.

With all their proven therapeutic effects, can probiotics replace drugs? According
to Tandon, probiotics can have therapeutic benefits but are not drugs. "Probiotics
are living micro organisms that are consumed in order to obtain a beneficial
effect regardless of their intrinsic nutritional value. They can be operationally
described as commensal organisms that can be harnessed for therapeutic benefit
but they are not drugs," asserts Tandon.

Discovery of probiotics

Fermented foods such as sour milk and cultured dairy
products containing beneficial bacteria have been consumed regularly as
a part of the human diet but their health benefits came to light only after
the publication of the book entitled The Prolongation of Life by Dr Elie
Metchnikof, a Russian biologist in 1908. After much research Metchnikof
theorised that reason behind the longevity of Bulgarian peasants was the
consumption of large quantities of cultured food especially yoghurt. These
foods were rich in lactic acid bacteria that helped to maintain the friendly
bacteria that live in the gut and prevented the production of toxins by
inhibiting the growth of pathogenic organisms. This led to much longer and
healthier lives among the Bulgarians.

Ever since there has been considerable interest in boosting
beneficial bacteria in the gut through fermented milk drinks that are
supplemented with these live bacteria. There are many food products available
globally that contain probiotic bacteria.

Side effects

Although, probiotics' safety has not been thoroughly studied scientifically,
experts say that some live microorganisms have a long history of use as probiotics
without causing illness in people. However, more information is required, especially
on how safe probiotics are for young children, elderly people, and people with
compromised immune systems. "Immuno-suppressed persons may develop systemic
infection from the probiotic bacteria given orally. So in that group and among
the elderly, one should be careful in using probiotics," suggests Tandon.

However, according to Kasarle, side effects due to probiotics, if they occur
at all, tend to be mild and digestive. "Probiotics might theoretically
cause infections that need to be treated with antibiotics, especially in people
with underlying health conditions. They could also cause unhealthy metabolic
activities, too much stimulation of the immune system, or gene transfer,"
says Kasarle.

Moving ahead

However, with more encouraging evidence from studies of specific probiotic formulations,
use of probiotics is rapidly moving towards clinical usage. Experts say that
scientific studies are providing mechanisms of action to explain therapeutic
effects, and randomised controlled trials are providing necessary evidence for
their incorporation into the therapeutic armamentarium. However, not all individual
probiotic strains have the same efficacy and future clinical trials may focus
on multi-strain preparations agents with known efficacy. According to Kasarle,
there is research going on to use probiotics to treat immuno-deficient disorders
such as Human Immuno-deficiency Virus (HIV), cancer and some chronic disorders
such as tuberculosis. Vaginal infection is also another area of research for
probiotics efficacy. "There are studies going on to control the exacerbation
of ulcerative colitis and the other to see its efficacy in microscopic colitis,"
informs Tandon.

Recent reports suggest that apart from gastrology-related drugs, new probiotic
drugs are being developed in areas like paediatrics, oral care and gynaecology.

Promising Indian market

Probiotic related functional foods have already captured the Indian market with
strong players like Yakult, Amul, Nestle and Mother Dairy launching innovative
probiotic products like drinks, ice creams, sweeteners, ready-to-eat cookies
and jellies with health claims. On the other hand, big pharmacos like DRL, Glenmark,
CD Pharma (a wholly owned subsidiary of VSL Pharma) and Alkem have already launched
drugs with these bugs. At present there exist over 40 probiotic drug brands
in India of which a majority are in the area of gastroenterology.

Further, the market is expected to grow exponentially. "India has a huge
market for probiotics because of the large number of people suffering from acute
diarrhoeal diseases," says Tandon. Many major Indian pharmacos are also
in the process of developing and in-licensing probiotic drugs. After launching
Inersan with Ranbaxy, VSL is also in talks with another big pharmaco to license
its lead drug VSL-3 used to treat irritable bowel syndrome that causes abdominal
pain, gas, diarrhoea and constipation.

"We intend to introduce products to treat problems of uterus, kidney, and
skin and are talking to various Indian drug makers. Ranbaxy would distribute
our product for gum related problems 'Inersan' in India and Nepal," says
K S Chadha, Country Head, CD Pharma India.

There are also other probiotic drugs like Enterogermina (from Sanofi-Aventis),
ViBact (USV), Darolac (Aristo), Pre-Pro (Fourrts), Bifilac (Tablet India), Sporlac
(Uni-Sankyo), Prowel and Sporotic (Alkem) and Econorm and Becelac (DRL) available
in the Indian market and enjoying huge market share. Alkem also manufactures
Fructo-oligo saccharides which helps the growth of good probiotic bacteria.

Need for awareness

However, industry experts feel that there is a lack of complete understanding
of probiotics in India. "In India people are becoming increasingly aware
of natural ways to good health and as the awareness about the benefits of probiotic
foods increases more and more people will start consuming them as a part of
their daily diet," opines Hajela. Chadha agrees, "Probiotics is a
new concept in India and is yet to be completely understood. Medical education
is needed to create awareness about probiotics."

The industry also feels that there is a crying need for regulatory guidelines
for use of probiotics. "Specificities of the bacteria and their doses need
to be established," says Tandon. Experts say that it should be recommended
that all manufacturers declare the strain of probiotic bacteria used and number
of bacteria present. This is an accepted norm globally, and in India too it
will go a long way to help the consumer make an informed choice. "It is
critical to understand that any probiotic food or drug has to have a bare minimum
quantity of bacteria to be effective," says Chadha.

Besides, in India there are no separate regulations dealing with dietary supplements,
health food supplements and nutraceuticals. Currently, in India products are
classified as food or drug under law. "New legislation governing the labelling
of probiotics, such as indicating the species, strain and number of bacteria
present is likely to come into force in the near future. These specific regulations
for the evaluation of probiotics in food will enable the consumer to make an
informed choice," opines Hajela. Indian Council of Medical Research (ICMR)
is also forming a task force committee to work to form guidelines for the use
of probiotics. According to Dr Sujit Kumar Bhattacharya, Additional Director
General of ICMR, Department of Biotechnology (DBT) is also working on regulatory
guidelines for use of probiotics and ICMR may join DBT on the job.

Probiotics has progressed from home-grown products to global brands and today
the consumer has variety and health within reach. As research leads the market,
this is surely one arena where the good will always win over the bad.